Track topics on Twitter Track topics that are important to you
The primary purpose of this study is to demonstrate the clinical safety and efficacy of LeGoo™ in comparison to a standard vessel occlusion method (i.e. vessel loops). Although LeGoo™ is suitable for use in any vascular surgery where temporary vessel occlusion is desired, this study specifically focuses on the use of LeGoo™ in off-pump coronary bypass (OPCAB), as a most sensitive model of adverse changes that may occur at any vascular site.
The purpose of this study is to evaluate the clinical efficacy of LeGoo™ as compared to a traditional vessel loop. LeGoo is a device that is intended to be used during surgical procedures to temporarily occlude blood vessels while forming an anastomosis. LeGoo™ will be evaluated in subjects undergoing off-pump coronary artery by-pass (OPCAB) surgery. This is a prospective, randomized trial with a 30-day follow-up period. Half of the eligible patients will be randomized to the experimental group (LeGoo™); and the other half to the control group (standard vessel loops).
LeGoo™ is polymer-based device which is comprised of a non-toxic and biocompatible gel that exists as a liquid at low temperatures and rapidly transitions to a solid at body temperature, forming a plug that can occlude blood vessels. LeGoo™ is injected into a blood vessel that is intended to be occluded, where it stays in a "plug" form for several minutes allowing the surgeon to work in a bloodless field. The gel dissolves with time (spontaneously) or can be reversed back to liquid instantly by cooling the site with ice or irrigating with cold saline. Once dissolved below a minimum concentration, the polymer can never re-solidify.
The primary research hypothesis is that surgeons will obtain a bloodless surgical field and achieve satisfactory hemostasis in a larger proportion of anastomoses using LeGoo™ than using a conventional temporary hemostasis technique.
Satisfactory hemostasis is defined by the surgeon who will quantitate his/her observation about the quality of the surgical field using the following scoring system:
1. - Excellent hemostasis (no bleeding)
2. - Minimal bleeding (bleeding does not interfere with suturing)
3. - Modest bleeding (required intermittent use of another device to control bleeding at the site of the anastomosis)
4. - Copious bleeding (required continuous use of another device)
"Excellent hemostasis" and "minimal bleeding" are considered "satisfactory hemostasis." Satisfactory hemostasis will constitute a treatment success for the purpose of evaluating the primary efficacy of LeGoo. The primary endpoint is the proportion of anastomoses in which satisfactory hemostasis is achieved.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Off Pump Coronary Artery Bypass Surgery
Klinik fur Herzchirurgie Herzzentrum Leipzig
Published on BioPortfolio: 2014-08-27T03:18:59-0400
The purpose of this study is to determine completeness of revascularization, graft patency, clinical outcomes, health-related quality of life and costs in 200 initial trial participants at...
Comparison of two operative techniques (on-pump vs off-pump)of coronary revascularisation of the best treatment concept for patients older or 75 years old. Hypothesis: The coronary bypass...
Ischemic heart disease is one of the most frequent diagnoses in the VA system. Moreover, 5,819 coronary artery bypass graft (CABG-only) procedures were performed in the VA in FY 1999. Thro...
The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bl...
The purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.
Respiratory complications are common after cardiac surgery and the use of extracorporeal circulation is one of the main causes of lung injury. We hypothesized a better postoperative respiratory functi...
Aspirin resistance (AR) has been reported to present after coronary artery bypass graft causing saphenous vein graft failure. We aimed to investigate the factors that affect the anti-platelet effect o...
There is an ongoing debate focusing on clinical outcomes after off-pump coronary artery bypass grafting (OPCAB) and on-pump coronary artery bypass grafting (ONCAB). The objective of present meta-analy...
To assess the safety and efficacy of tranexamic acid (TA) on off-pump coronary artery bypass (OPCAB) surgery.
Off-pump coronary artery bypass grafting (OPCAB) is one of the standard treatments for coronary artery disease (CAD) while hybrid coronary revascularization (HCR) represents an evolving revascularizat...
Coronary artery bypass surgery on a beating HEART without a CARDIOPULMONARY BYPASS (diverting the flow of blood from the heart and lungs through an oxygenator).
Direct myocardial revascularization in which the internal mammary artery is anastomosed to the right coronary artery, circumflex artery, or anterior descending coronary artery. The internal mammary artery is the most frequent choice, especially for a single graft, for coronary artery bypass surgery.
Surgical therapy of ischemic coronary artery disease achieved by grafting a section of saphenous vein, internal mammary artery, or other substitute between the aorta and the obstructed coronary artery distal to the obstructive lesion.
Abdominal artery that follows the curvature of the stomach. The right gastroepiploic artery is frequently used in CORONARY ARTERY BYPASS GRAFTING; MYOCARDIAL REVASCULARIZATION, and other vascular reconstruction.
A complication of INTERNAL MAMMARY-CORONARY ARTERY ANASTOMOSIS whereby an occlusion or stenosis of the proximal SUBCLAVIAN ARTERY causes a reversal of the blood flow away from the CORONARY CIRCULATION, through the grafted INTERNAL MAMMARY ARTERY (internal thoracic artery), and back to the distal subclavian distribution.
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells. In vertebrates, it is composed of blo...